Note: The advisory committee made its recommendations, but now that has be evaluated by the FDA itself do decide what to do. They could decide to do nothing at all (not likely due to all the press there), take it off the market (what I want but not likely), change the labels, or the last option is require the patient to sign off that they understand the devastating effects before taking any of these drugs; A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS).

This is a win for the people over Big Farma given the constraints of the day.

“The panel voted overwhelmingly that the benefits and risks for the systemic fluoroquinolone antibacterial drugs do not support the current labeled indications for the treatment of ABS (unanimous), ABECB-COPD (2 yes, 18 no, 1 abstention), or uncomplicated urinary tract infection (1 yes, 20 no). Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and gemifloxacin.” ~Troy Brown, RN

“Testimonies from patients who described the wide range of harmful side effects have spurred the FDA into action.” ~Alyssa Navarro

“Fluoroquinolone labels need much stronger warnings about the risks for serious adverse events, including tendinitis and tendon rupture, and peripheral neuropathy, the panel said. Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, ofloxacin, and gemifloxacin. In India, popular brands of fluoroquinolones include Ciplox, Ciprobid, Levoflox and Oflox.” ~Rupali Mukherjee

Acute Bacterial Sinusitis - Antibacterial Efficacy:

[FDA] reviewed 20 placebo controlled trials published in the medical literature (see bibliography in Appendix A). Fourteen studies did not show a statistically significant difference over placebo.

Acute Exacerbations of Chronic Bronchitis - Antibacterial Efficacy:

[FDA] reviewed 15 placebo controlled studies of ABECB COPD (see bibliography in Appendix A). Nine studies did not show a difference in clinical outcomes between patients who received placebo and patients who received an antibacterial drug. Six studies showed a statistically significant difference in favor of an antibacterial drug, although the studies enrolled patients with varying disease severity and used different outcome assessments…

Uncomplicated Urinary Tract Infection - Antibacterial Efficacy:

There is a clear and consistent treatment effect of antibacterial drug therapy for treatment of uUTI on the outcome assessment of microbiologic eradication. In studies that used a placebo control, there is a similar treatment effect using an outcome assessment based on symptom resolution. In a study that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.

Additionally, in the meeting brief and this 617 page PDF, the FDA identified a syndrome associated with fluoroquinolone toxicity—one that “floxies” have been pushing for recognition of for years. It is called Fluoroquinolone Associated Disability (FQAD). According to the FDA:

“While most of the individual AEs (adverse events) that exist within FQAD (fluoroquinolone associated disability) are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

The FDA has posted the videos of the November 5th 2015 Fluoroquinolone Antibiotics hearing.

The Center for Drug Evaluation and Research (CDER) provided a live webcast of the November 5, 2015, joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

A recording of the webcast can be found at the following address. The last two are the most interesting: